Effects of Canola Oil and Coconut Oil on Postprandial Metabolism in Older Adults With Increased Cardiometabolic Risk

Sponsor

University of Bonn (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05208346

Collaborator

Union for the Promotion of Oil and Protein Plants (UFOP, Germany) (Other)

Enrollment

Location

Arms

3.7

Anticipated Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to investigate the postprandial effects of fat content and fatty acid composition of mixed meals on parameters associated with cardiometabolic diseases. Therefore, older subjects with increased risk of cardiometabolic diseases consume 4 mixed meals with 25 or 50 g of either canola or coconut oil. In a postprandial period of 6 hours, outcomes associated with cardiometabolic risk (e.g., triglycerides) are analyzed.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Metabolic Syndrome	Dietary Supplement: Mixed meals	N/A

Detailed Description

In a crossover design, 30 older men and women with increased risk of cardiometabolic diseases consume 4 mixed meals, enriched with either 25 or 50 g canola or coconut oil. During a postprandial period of 6 hours, parameters of lipid metabolism (e.g., plasma triglycerides), glucose metabolism (e.g., plasma glucose, serum insulin), as well as markers of inflammation (e.g., IL-6), vascular system (e.g., pulse wave velocity) and antioxidant system (e.g., trolox equivalent antioxidative capacity) are analyzed. Furthermore, amino acid profile (e.g., L-arginine), fatty acid profile, neuropsychologic parameters (e.g., appetite) and satiety-associated hormones (e.g., PYY) are assessed. Each intervention arm will be separated by a washout period of 14 days.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

Acute Effects of Canola Oil Compared With Coconut Oil on Postprandial Metabolism in Women and Men With Increased Risk for Cardiometabolic Diseases

Anticipated Study Start Date :

Mar 9, 2022

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Canola oil high-fat Participants randomized to receive a mixed meal with 50 g canola oil	Dietary Supplement: Mixed meals Mixed meals enriched with either 25 or 50 g of canola or coconut oil
Experimental: Coconut oil high-fat Participants randomized to receive a mixed meal with 50 g coconut oil	Dietary Supplement: Mixed meals Mixed meals enriched with either 25 or 50 g of canola or coconut oil
Experimental: Canola oil low-fat Participants randomized to receive a mixed meal with 25 g canola oil	Dietary Supplement: Mixed meals Mixed meals enriched with either 25 or 50 g of canola or coconut oil
Experimental: Coconut oil low-fat Participants randomized to receive a mixed meal with 25 g coconut oil	Dietary Supplement: Mixed meals Mixed meals enriched with either 25 or 50 g of canola or coconut oil

Outcome Measures

Primary Outcome Measures

Parameters of lipid metabolism in blood I [Postprandial period of 6 hours]
Measurement of triglycerides (mg/dl)
Parameters of lipid metabolism in blood II [Postprandial period of 6 hours]
Measurement of total cholesterol (mg/dl)
Parameters of lipid metabolism in blood III [Postprandial period of 6 hours]
Measurement of LDL cholesterol (mg/dl)
Parameters of lipid metabolism in blood IV [Postprandial period of 6 hours]
Measurement of HDL cholesterol (mg/dl)
Parameters of lipid metabolism in blood V [Postprandial period of 6 hours]
Measurement of ApoB48 (g/L)
Parameters of lipid metabolism in blood VI [Postprandial period of 6 hours]
Measurement of free fatty acids (mmol/L)
Parameters of glucose metabolism in blood I [Postprandial period of 6 hours]
Measurement of glucose (mg/dl)
Parameters of glucose metabolism in blood II [Postprandial period of 6 hours]
Measurement of insulin (nmol/L)

Secondary Outcome Measures

Assessment of hunger [Postprandial period of 6 hours]
Assessment of hunger via visual analogue scale (0 = not hungry at all, 10 = very hungry)
Assessment of attention [Postprandial period of 6 hours]
Assessment of attention via validated neuropsychological questionnaires (paper-pencil)
Postprandial endothelial function [Postprandial period of 6 hours]
Performance of pulse wave analysis with the Vicorder device (measurement of pulse wave velocity in m/s)
Parameters of endothelial function in blood [Postprandial period of 6 hours]
Measurement of blood parameters of endothelial function (e.g., ADMA in µmol/L)
Postprandial inflammation [Postprandial period of 6 hours]
Measurement of parameters of inflammation in blood (e.g., IL-6 in pg/ml)
Antioxidant system [Postprandial period of 6 hours]
Measurement of parameters of antioxidant system in blood (e.g., TEAC in mmol Trolox equivalents/L)
Fatty acid profile [Postprandial period of 6 hours]
Analysis of fatty acid profile in serum (e.g., alpha-linolenic acid in µmol/L)
Amino acid profile [Postprandial period of 6 hours]
Analysis of amino acid profile in blood (e.g., L-arginine in nmol/ml)

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

BMI: 27 - 34,9 kg/m2
Waist circumference: women ≥ 80 cm, men ≥ 94 cm
At least two of the following criteria of metabolic syndrome:

Fasting triglycerides in serum: ≥ 150 mg/dl Fasting HDL-Cholesterol in serum: women < 50 mg/dl, men < 40 mg/dl Systolic blood pressure: ≥ 130 mmHg, diastolic blood pressure: ≥ 85 mmHg Fasting glucose in plasma: ≥ 100 mg/dL

Exclusion Criteria:

Smoking
Diseases that may impact outcome measures (e.g., thyroid diseases, insulin-dependent diabetes mellitus, impaired renal function, tumors, anemia)
Intake of immunosuppressives or supplements (e.g., fish oil)
Participation in another study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Bonn	Bonn		Germany	53115

Sponsors and Collaborators

University of Bonn
Union for the Promotion of Oil and Protein Plants (UFOP, Germany)

Investigators

Principal Investigator: Sarah Egert, Prof. Dr., University of Bonn

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Dr. Sarah Egert, Prof. Dr. Sarah Egert, University of Bonn

ClinicalTrials.gov Identifier:

NCT05208346

Other Study ID Numbers:

528/191

First Posted:

Jan 26, 2022

Last Update Posted:

Mar 17, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Prof. Dr. Sarah Egert, Prof. Dr. Sarah Egert, University of Bonn

Postprandial metabolic events

Additional relevant MeSH terms:

Cardiovascular Diseases

Metabolic Syndrome

Study Results

No Results Posted as of Mar 17, 2022